Modafinil

Product NDC
42043-161
11-digit product format
420430161
Labeler code
42043
Product ID
42043-161_dc738068-3e56-47c5-afd8-7d471303c041
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Modafinil
Dosage form
TABLET
Route
ORAL
Labeler
OrchidPharma Inc
Application
ANDA078963
Marketing category
ANDA
Marketing start
2013-08-01
Marketing end
0000-00-00
Substance
MODAFINIL
Active strength
200 mg/1
Pharmacologic classes
Central Nervous System Stimulation [PE],Increased Sympathetic Activity [PE],Sympathomimetic-like Agent [EPC]
DEA schedule
CIV
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
91b7dea8-da1b-abb1-9750-2e680cd894b6Product name220171005

FDA-Initiated Inactive NDC Indexing#

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
205324modafinil 200 MG Oral TabletPSN7e642144-a267-40b2-8684-a2cfbb7acc5f3
205324modafinil 200 MG Oral TabletSCD7e642144-a267-40b2-8684-a2cfbb7acc5f3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
42043-161-01420430161011 BOTTLE, PLASTIC in 1 CARTON (42043-161-01) > 100 TABLET in 1 BOTTLE, PLASTIC2013-08-010000-00-00NoNoCurrent
42043-161-03420430161031 BOTTLE, PLASTIC in 1 CARTON (42043-161-03) > 30 TABLET in 1 BOTTLE, PLASTIC2013-08-010000-00-00NoNoCurrent
42043-161-90420430161901 BOTTLE, PLASTIC in 1 CARTON (42043-161-90) > 90 TABLET in 1 BOTTLE, PLASTIC2013-08-010000-00-00NoNoCurrent